LEXXEMA 1 mg/g CUTANEOUS EMULSION

2. What You Need to Know Before Starting to Use Lexxema Emulsion

Do not use Lexxema emulsion

• If you are allergic to the active ingredient methylprednisolone aceponate (MPA) or to any of the other components of this medication (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections, such as chickenpox or herpes.
• In areas of skin affected by inflammation that is red/pink (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophic skin diseases).
• In areas of skin showing a vaccination reaction, such as redness or inflammation after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless they are also being treated with specific treatment).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Lexxema emulsion.

Be particularly careful if your doctor diagnoses a skin infection caused by bacteria or fungi; then, you should also use the additional prescribed treatment for the infection, as the infection may worsen if not treated.

Anti-inflammatory medications (corticosteroids), such as the active ingredient (MPA) of Lexxema emulsion, have significant effects on the body. It is not recommended to use Lexxema emulsion on large areas of skin or for extended periods, as this significantly increases the risk of side effects.

To reduce the risk of side effects:

• Use the lowest possible dose.
• Use it only for the time absolutely necessary to relieve the skin condition.
• Lexxema emulsion should not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (such as the anal or genital area).
• Lexxema emulsion should not be used on large areas of skin (more than 40% of the body surface).
• Lexxema emulsion should not be used under airtight and waterproof materials, including bandages, dressings, clothing, or diapers, unless prescribed by your doctor.

If you use Lexxema emulsion for conditions other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment more difficult.

Contact your doctor if you experience blurred vision or other visual disturbances.

If Lexxema emulsion is applied to the anal or genital area, some of its components may cause deterioration of latex products, such as condoms or diaphragms. Therefore, these products may no longer be effective as contraceptives or protectors against sexually transmitted diseases, such as HIV infection. Contact your doctor or pharmacist if you need more information.

Children

• Use Lexxema emulsion as little as possible to reduce the risk of side effects.
• Lexxema emulsion should not be used under airtight and waterproof materials, such as diapers, unless prescribed by your doctor.
• Lexxema emulsion can be used in children between 4 months and 3 years if prescribed by your doctor. It is not recommended for use in children under 4 months of age.

Using Lexxema Emulsion with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications, including those purchased without a prescription.

No interactions between Lexxema emulsion and other medications are known at present.

Pregnancy, Breastfeeding, and Fertility

To avoid any risk to the child, do not use Lexxema emulsion if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, unless your doctor advises you to do so.

If your doctor recommends using Lexxema emulsion during breastfeeding, do not apply the medication to the breasts; do not let the child come into contact with treated areas.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

Lexxema emulsion does not affect your ability to drive or operate machinery.

Lexxema Emulsion Contains Benzyl Alcohol

This medication contains 1.25 g of benzyl alcohol per 100 g.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to Use Lexxema Emulsion

Follow your doctor's or pharmacist's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Unless your doctor tells you otherwise, the recommended dose is:

• Apply Lexxema emulsion in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, the treatment duration with Lexxema emulsion should not exceed two weeks. Always make the treatment as short as possible.
• If you use Lexxema emulsion for a skin rash with inflammation and scaling on the face (seborrheic eczema), do not treat for more than one week.
• If your skin becomes too dry, consult your doctor. You may need to apply a regulating fatty ointment in addition.

Use in Children

Lexxema emulsion can be used in children between 4 months and 3 years if prescribed by your doctor. No dose adjustments are required.

The use of Lexxema emulsion is not recommended in children under 4 months of age due to the lack of safety data.

If You Use More Lexxema Emulsion Than You Should

No risk is expected after a single overdose of Lexxema emulsion (too much, too large an area, or too frequent use). Repeated overdoses may produce side effects (see section 4, Possible Side Effects).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If You Forget to Use Lexxema Emulsion

Do not use a double dose to make up for forgotten doses; if you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in the package leaflet.

If You Stop Using Lexxema Emulsion

If you stop using Lexxema emulsion prematurely, the original symptoms of your skin problem may recur. Please contact your doctor before stopping treatment with Lexxema emulsion.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Lexxema emulsion can cause side effects, although not everyone gets them.

The assessment of side effects is based on the following frequencies:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from the available data.

• Common:
• • Local skin irritation (such as burning sensation)

• Uncommon:
• • Pain
  • Itching
  • Small blisters and pustules
  • Scaling
  • Superficial wounds (erosion)
  • Worsening or recurrence of eczema
  • Cracking of the skin

The use of anti-inflammatory medications, called corticosteroids (such as the active ingredient of Lexxema emulsion), on the skin may lead to the following side effects (frequency not known).

• Thinning of the skin (atrophy)
• Dry skin
• Redness (erythema)
• Appearance of red spots
• Inflammation of the hair follicle (folliculitis)
• Stretch marks
• Acne
• Specific skin inflammation around the upper lip and chin (perioral dermatitis).
• Allergic skin reaction (contact dermatitis)
• Changes in skin color
• Increased hair growth
• Side effects may occur not only in the treated area but also in completely different areas of the body. This occurs if the active ingredient (a corticosteroid) passes into the body through the skin (is absorbed). This, for example, can increase pressure in the eye (glaucoma).
• Blurred vision.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lexxema Emulsion

Keep this medication out of the sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Validity period after first opening: 3 months.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lexxema Emulsion

• The active ingredient is methylprednisolone aceponate (MPA).
• The other ingredients (excipients) are: medium-chain triglycerides, capric/caprylic/myristic/stearic triglyceride, macrogol-2-stearate, macrogol-21-stearate, benzyl alcohol, disodium edetate, glycerol (E-422) (85%), and purified water.

Appearance of the Product and Package Contents

Lexxema emulsion is a white cutaneous emulsion (similar to an opaque milky cream) and is available in 20 and 50 g tubes.

The tubes have a removable seal.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid) - Spain

Manufacturer:LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Date of Last Revision of this Package Leaflet: August 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/